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Full-Text Articles in Health Law and Policy
Machine Learning-Based Medical Devices: The Fda’S Regulation, Requirements, And Restrictions, Charli Beam
Machine Learning-Based Medical Devices: The Fda’S Regulation, Requirements, And Restrictions, Charli Beam
Journal of Law and Health
The FDA should create functional regulations for the growing number of machine learning medical devices. The healthcare system is increasingly using these devices for diagnosis. Machine learning devices trained on biased data sets are susceptible to furthering certain types of bias and generating flawed outcomes. The FDA should require ML medical devices to include a label that describes the demographics of the tested population. If manufacturers fail to include this information, the FDA could determine the label false or misleading under §502 of the FD&C Act and stop sales of the device. After approval, the FDA should use §814.89(2) and …
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie
Journal of Law and Health
The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this …
Is Law The Prescription That Can Cure Medicine?, Samuel Gorovitz
Is Law The Prescription That Can Cure Medicine?, Samuel Gorovitz
Journal of Law and Health
Now medical care has been transformed. We recognize that the human organism is a complex interaction of many different systems-respiratory, circulatory, neurological, digestive, and so on. Some of them can fail and create both problems and opportunities we did not formerly have. One of the opportunities we now have is that we can keep people alive who in an earlier era would not have survived. And one of the problems we now have is also that we can keep people alive who in an earlier era would not have survived. Some of them are kept alive with such diminished capacity …